Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

Refractory Glaucoma Clinical Trial

Official title:

A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00349414
• Other study ID #: DSRB Reference Code: A/06/164
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 6, 2006
• Last updated: May 13, 2008
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2008
• Source: National University Hospital, Singapore
• Contact: Anna Tan, MMed
• Phone: 6772-5317
• Email: amwttan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.

Description:

End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• · More than 21 years old

• Advanced glaucoma refractory to maximum tolerated medical and surgical treatment

• Visual acuity worse than 6/60

• Poor candidates for additional filtration surgery

Exclusion Criteria:

• · Any eye surgery done within 2 months of enrolment

• Any ocular infection or inflammation

• Unable to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Glaucoma
• Glaucoma
• Refractory Glaucoma

Intervention

Procedure:
• Micropulse Transscleral Cyclophotocoagulation

• Conventional Transscleral Cyclophotocoagulation

Locations

Country	Name	City	State
Singapore	National University Hospital Singapore Department of Ophthalmology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15. — View Citation

Ho CL, Wong EY, Chew PT. Effect of diode laser contact transscleral pars plana photocoagulation on intraocular pressure in glaucoma. Clin Experiment Ophthalmol. 2002 Oct;30(5):343-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months
Secondary	Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage